Pancreatic Volume in Preclinical Type 1 Diabetes

Study Name: Non-Invasive Assessment of Pancreatic Volume as a Tool to Augment Risk Stratification in Patients at Risk for Type 1 Diabetes

Principal Investigator: Michael Haller, M.D.

Study Coordinator: Miriam Cintron

Phone: (352) 273-5580

What is the Non-Invasive Assessment of Pancreatic Volume as a Tool to Augment Risk Stratification in Patients at Risk for Type 1 Diabetes study?

The purpose of the study is to determine differences in pancreatic volume between new-onset Type 1 Diabetes (T1D) patients, antibody positive subjects at increased risk for T1D, and healthy controls. It will also be used to determine if pancreatic volume correlates with indirect biochemical markers of endocrine and exocrine pancreatic function.

Type 1 diabetes is characterized by a progressive destruction of insulin producing beta cells, resulting in lifelong dependence on exogenous insulin. While beta cells make up less than 1% of the pancreas, studies have demonstrated that T1D is associated with a marked reduction of pancreatic mass at diagnosis and as the disease progresses. As such, if pancreatic volume assessment, by ultrasonography (US) or MRI (Magnetic Resonance Imaging), could be utilized as a marker of beta cell function in high risk patients, non-invasive pancreatic imaging could become an important part of staging diabetes risk.

This study will help researchers determine whether people who are at high risk of type 1 diabetes start out with smaller pancreas volume or whether the beginning of the onset of the disease causes the pancreas volume to shrink.

Who can participate?

By using traditional, non-invasive tools such as MRI and ultrasound, UF Health researchers will measure and estimate the pancreas volumes of four sets of individuals between the ages of 10 and 45 years of age:

People who have recently been diagnosed with Type 1 diabetes

People at little risk of developing the disease who are matched with the other groups based on age, gender, and BMI.

People at risk of developing Type 1 diabetes due to the presence of serum autoantibodies (those with single and multiple autoantibodies)

Researchers plan to recruit 100 patients per year for three years, from Florida and the southeast region.

What do I have to do as a participant?

Healthy volunteers who meet the inclusion and exclusion criteria and who are willing and able to independently give written informed consent, will undergo non-invasive MRI and/or ultrasound tests. This is a one day study visit. Participants are compensated for their time and will incur no expense for test services.